For Industry

FY2017 MDUFA User Fees

The Fees for Fiscal Year 2017 (October 1, 2016 through September 30, 2017) are as follows:

FY17 User Fees (in U.S. Dollars)

Application TypeStandard FeeSmall Business Fee
PMA, PDP, PMR, BLA$234,495$58,624
panel-track supplement$175,871$43,968
180-day supplement$35,174$8,794
real-time supplement$16,415$4,104
BLA efficacy supplement$234,495$58,624
PMA annual report$8,207$2,052
30-day notice$3,752$1,876

† For small businesses with an approved SBD.

‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $3,382

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.

Page Last Updated: 09/30/2016
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